Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula
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|ClinicalTrials.gov Identifier: NCT01612195|
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : May 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Complex Anal Fistula||Procedure: Anal fistula plug||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||January 2012|
|Experimental: Anal fistula plug||
Procedure: Anal fistula plug
All patients have a draining seton for at least 6 weeks prior placement of the anal fistula plug. All patients are administered a general anesthetic and are operated in the lithotomy position. The seton is removed, but no curettage or irrigation of the fistula tract is performed. The plug is inserted through the internal opening, and pulled through the external opening until it fit snugly and its base is sutured to the internal sphincter with 2 interrupted 2-0 polyglactin 910 sutures. The tip of the plug is cut at skin level and not sutured. The external opening is left open to allow for drainage. The patient is instructed to restrict physical and sexual activity for 2 weeks postoperatively. Patients are seen in the post-operative clinic at 10 days, 6 weeks and 6 months as per protocol.
Other Name: Anal fistula plug Surgisis®
- Fistula healing [ Time Frame: 6 months ]Clinical healing of a complex anal fistula as assessed in the clinic at 6 weeks and 6 months after anal fistula plug surgery. Further assessment prn.
- Anal continence [ Time Frame: 6 months ]Evaluation of anal continence by means of a validated questionnaire, namely the Fecal Incontinence Severity Index, at 6 weeks and 6 months after anal fistula plug surgery.
- Quality of life [ Time Frame: 6 months ]Evaluation of health-related quality of life by means of a validated questionnaire, namely the Short-Form 36 version 2, at 6 weeks and 6 months after anal fistula plug surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612195
|University of Basel & Kantonsspital St.Gallen|
|Basel & St.Gallen, Switzerland, 4031 & 9007|
|Principal Investigator:||Michel Adamina, MD, PD, MSc||University of Basel|